DOI: 10.1089/end.2018.0029 1 Securing Mesh with Delayed

Page 1 of 18 Journal of Endourology

© Mary Ann Liebert, Inc.

DOI: 10.1089/end.2018.0029

1

Securing Mesh with Delayed Absorbable Suture Does Not Increase

Risk of Prolapse Recurrence Following Robotic Sacral Colpopexy

Authors: CR Powell, Isamu Tachibana, Bridget Eckrich, Jeffrey Rothenberg, and Jon

Hathaway

Introduction and Objective: NON‐absorbable monofilament suture is traditionally used to

secure vaginal mesh for Robotic Assisted Sacral Colpopexy (RASC) but can become exposed

postoperatively requiring invasive vaginal removal. Polydioxanone delayed absorbable

suture may avoid this. We sought to determine the objective and subjective impact of

suture choice for mesh fixation.

Methods: A cohort study was undertaken using a prospective registry and subjects were

grouped based on type of suture at the time of RASC. Apical failure was defined as C point

descent of greater than 2cm, Anterior compartment failure was defined as POP‐Q Ba point

of >0, and Posterior compartment failure was defined as Bp point of >0. Patient reported

outcomes included UDI‐6 and QoL. 2‐tail T‐test and Chi‐squared were used for analysis.

Results: 119 women underwent RASC between 2009 and 2016. Patients had similar

preoperative characteristics (Table 1). All POP‐Q, UDI‐6, and QoL scores improved

postoperatively (Table 1 and 2). Apical failure was noted in 0, Anterior failure was noted in

7 (average Ba +1.1 cm in failures), and Posterior failure was noted in 4 (mean Bp +1.0 cm)

at 16 months’ follow up. Failures in the anterior compartment were much more common

in the NON‐absorbable monofilament cohort (Table 2). Failures in the apical and posterior

compartments were not significantly different between groups. 9 suture erosions were

noted in the NON‐absorbable monofilament cohort, 5 requiring excision in the clinic and 2

in the operating room. 2 suture erosions were noted in the delayed‐absorbable cohort, 0

required excision. Postoperative UDI‐6 and QoL scores did not vary significantly between

groups (5.3±4.0 vs. 5.1±4.0, p=NS, 2.8±2.0 vs. 2.8±2.2, p=NS).

Conclusion: Securing mesh with delayed‐absorbable monofilament did not appear to

increase risk of failure in patients undergoing RASC and eliminates the need for suture

excision postoperatively.

____________________________________________________

This is the author's manuscript of the article published in final edited form as: Powell, C. R., Tachibana, I., Eckrich, B., Rothenberg, J., & Hathaway, J. (2020). Securing Mesh with Delayed Absorbable Suture Does Not Increase Risk of Prolapse Recurrence Following Robotic Sacral Colpopexy. Journal of Endourology, (ja). https://doi.org/10.1089/end.2018.0029

https://doi.org/10.1089/end.2018.0029

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2 Introduction:

Abdominal sacral colpopexy has been the most durable treatment for severe pelvic organ

prolapse (POP). Traditionally this has required an open incision, and this likely dissuaded

many women from electing for surgery, because of perceived surgical morbidities1.

Laparoscopic sacral colpopexy has been noted to have similar outcomes, with shorter

hospital stays and improved pain, but has not been widely adopted by surgeons

specializing in POP2. After the introduction of the robotic da Vinci Surgical platform

(Intuitive Surgical, Sunnyvale, CA, USA) to manage POP, utilization of robotic assisted

laparoscopic sacral colpopexy has been increasing nationwide 3. Recent meta‐analysis

demonstrated equivalent outcomes for abdominal sacral colpopexy and robotic‐assisted

sacral colpopexy (RASC). The authors reviewed over 1400 RASC procedures described in

the literature highlighting the growing popularity of this approach 4. The complications of

RASC are not as well described in the literature as those for the open technique. Mesh

extrusion has received significant media and scientific attention recently and is well

recognized by most patients. NON‐absorbable monofilament polypropylene suture

(Prolene®, Johnson&Johnson, New Brunswick, NJ, USA) is typically used to secure the

mesh, and suture extrusion can be very distressing to the patient and often requires

invasive suture trimming in the clinic or operating room. Some have suggested anchoring

mesh to the vaginal wall using monofilament delayed absorbable polydioxanone suture

(PDS®, Johnson&Johnson, New Brunswick, NJ, USA) instead of NON‐absorbable

monofilament to avoid this complication. Authors’ note: the use of the trade name is not

intended to imply that the branded product is superior, but it was thought that these trade

names would be familiar to many of the readers and so are used but sparingly. In addition,

some time may be saved by placing these sutures in a running fashion to secure mesh as

opposed to the traditionally described interrupted technique. The aim of this study is to

compare two techniques to secure vaginal mesh– interrupted NON‐absorbable

monofilament sutures versus running DELAYED‐ABSORBABLE MONOFILAMENT sutures.

Data is taken from a single‐institution experience with RASC and is retrospective. The

hypothesis is that both techniques will deliver similar outcomes, but the latter will avoid

the need to extract sutures that perforate the vaginal wall.

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3 Materials and Methods:

After institutional review board approval, a systematic review of the prospectively

collected Indiana University Sacral colpopexy database was undertaken to identify women

who underwent robotic‐assisted sacral colpopexy (RASC) between August 2009 and

December 2016. The results of the last documented clinic follow up were reported. All

patients undergoing simultaneous hysterectomy had gynecologic consultation. Technique

for hysterectomy (robotic supracervical hysterectomy versus robotic total hysterectomy)

was left to the discretion of the consulting gynecologist (JMR and JH). Demographic

variables were collected from the pre‐operative, intra‐operative and post‐operative

periods.

Concomitant procedures, such as mid urethral sling, culdoplasty, or vaginal cystocele

repair were performed in some, but not all, patients. The decision to perform concomitant

procedures was left to the discretion of the urologist and patient (CRP). All patients were

counseled about the possibility of postoperative urinary incontinence, suture extrusion,

mesh erosion, and the possible need for a staged continence procedure during

preoperative consultations.

RASC was performed using da Vinci® Surgical System (Intuitive Surgical, Sunnyvale, CA,

USA). The technique can be broken into 11 stages and viewed on the Journal of

Endourology Video Atlas (http://online.liebertpub.com/loi/END). Special attention should

be paid to a few areas:

I. Positioning and port placement: The patient is positioned on the table as shown in

Figure 1, it is important that the arms are tucked to the sides and padded

generously. Take care to pad between IV catheters and the skin. The four‐arm

robotic port site location on the abdomen is detailed in Figure 2. The robot can be

positioned between the legs, or to the side of the left leg to maintain access to the

vaginal area (aka “side docking”). The side‐docking technique is may lead to

crashing of arm 2 and 3 with the DaVinci SI ® system but careful planning can avoid

this. An assistant port can be 5mm which is not large enough to pass needles,

8mm, or 12mm depending on the surgeon’s preference. After placing ports,

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4 twenty‐seven degrees of Trendelenburg position is used to allow the bowel to fall

out of the pelvis. Initially, vaginal retraction was performed with a hand‐held

Lucite vaginal retractor or sponge‐stick. A bed‐mounted vaginal manipulator is also

available (Uterine Positioning System, Cooper Surgical, Trumbull, CT, USA) to

facilitate anterior and posterior dissection of the vagina and is more stable for

vaginal wall suturing. This is shown in Figures 3 and 4.

II. Anterior and Posterior vaginal wall dissection: The bladder can be filled with saline

to better identify the reflection of the bladder. The anterior dissection is taken

down to the level of bladder trigone (5‐10cm) while the posterior vaginal wall

dissection is carried to the rectovaginal space (5‐10cm). A useful measurement

tool is the gray insulation on the DaVinci® monopolar scissor device which

measures 5 cm from the tip of the scissor to the proximal end of the insulation.

III. Secure mesh to the anterior and posterior vaginal wall: This can be done in

interrupted or running fashion, with delayed absorbable suture or NON‐absorbable

suture. The results section will describe our results with both techniques. The key

is to use the #3 robotic arm and intra‐vaginal retractor to optimize exposure. In

addition to polypropylene mesh, porcine dermis and autologous fascia lata can be

used.

Pelvic Organ Prolapse Quantification (POP‐Q) exam was performed and recorded

preoperatively and post‐operatively on every patient. Treatment failure was defined

as recurrent apical prolapse greater than 2cm or any leading edge beyond the hymen

(Ba>0 or Bp>0). Surgical characteristics examined included type of sutures used for

mesh fixation, prior surgical history including prolapse and incontinence procedures,

POP‐Q exam, and validated quality of life instruments such as UDI‐6 and IIQ‐7.

Perioperative complications included vaginal suture extrusion, vaginal mesh extrusion,

port site hernia, deep venous thrombus (DVT), atrial fibrillation, mesh extrusion,

prolonged intubation, and wound infection. The decision to remove sutures was made

by the patient and the surgen, and the decision to remove them in the operating room

was made by the patient. The study was approved by the Indiana University School of

Medicine Institutional Review Board. Statistical analyses were performed using

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5 Microsoft Excel® (Microsoft Corp, Redmond, Washington, USA) and SPSS version 20.0

(IBM, Chicago, IL, USA). Categorical variables were analyzed for significance with Chi‐

Squared analysis and continuous variables were analyzed with 2‐tailed Student’s T‐test.

Results:

119 women underwent RSC between 2009‐2016. Patients had similar preoperative

characteristics (Table 1). Fifty‐three presented with hysterectomy prior to RSC, 15 with

prior vaginal prolapse repair, as well as 8 with prior incontinence procedures. Patients

also underwent procedures at the time of colpopexy. 66 underwent robotic supracervical

or total hysterectomy, 34 had mid urethral sling at the time of colpopexy, 22 had

culdoplasty for enterocele, and 5 had concomitant anterior vaginal wall suspension. POP‐

Q, UDI‐6, and QoL scores improved post operatively (Table 2). Apical failure was not

noted in any, Anterior failure was seen in 7 (average Ba was +1.1 cm in failures), and

Posterior failure was seen in 4 (mean Bp was +1.0 cm) at 16 months’ mean follow up.

Failures in the anterior compartment were much more common in the NON‐absorbable

monofilament cohort (Table 3). Failures in the apical and posterior compartments were

not significantly different between groups. 9/49 suture erosions were noted in the NON‐

absorbable monofilament cohort, 5 requiring excision in the clinic, 2 in the operating

room, and 2 not requiring intervention. 2/70 suture erosions were noted in the DELAYED‐

ABSORBABLE MONOFILAMENT cohort, 0 required intervention. Post‐operative UDI‐6 and

QoL scores did not vary significantly between groups (5.3±4.0 vs. 5.1±4.0, p=NS, 2.8±2.0 vs.

2.8±2.2, p=NS). Complications did occur. 2 wound infections were managed with

antibiotics (Clavien‐Dindo classification Grade II 7) and 2 vaginal mesh erosions were

noted. One prolonged intubation occurred, and she was successfully extubated on POD#2.

One new‐onset episode of atrial fibrillation was observed. Three port site hernias were

noted post operatively, always at the 12mm lateral assistant port site, one required

operative intervention (Clavien‐Dindo Grade IIIb), and the other two were managed non‐

operatively (Clavien‐Dindo Grade I). One of the vaginal mesh erosion events occurred

following total hysterectomy at the time of colpopexy, requiring surgical intervention

(Clavien‐Dindo Grade IIIb). The other patient had undergone hysterectomy prior to RASC,

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6 had no recognized vaginotomy, was asymptomatic, and chose non‐operative

management (Clavien I).

Discussion:

Compared to other contemporary RASC series, this series is the first to compare failure

rates between delayed absorbable monofilament suture (PDS®) and permanent NON‐

absorbable monofilament (Prolene®). Vaginal suture extrusion is not reported as a

complication in many series, but certainly contributes to patient morbidity, and appears to

be more common than vaginal mesh exposure, at least in this series. The low rates of

suture extrusion made descriptive statistics less meaningful, but the trend in this series is

clear. Ploumidis et al. reported an intraoperative and postoperative complication rate of

3.2% in a cohort of 95 women who underwent RASC8. In that study, less than half of the

patients had prior abdominal surgery and no patients had concomitant hysterectomy. In

one large RASC series, Nosti et al. found an overall complication rate of 7% in a group of

262 women of which approximately 43% of women had prior abdominal surgeries9.

Women in the present series were more likely to have previous hysterectomy (44.6%) and

concomitant hysterectomy (55.4%).

Our port site hernia rate of 2.5% was higher than the reported rates of 0 to 1.6% in other

contemporary series9‐11, but not all RASC series report on port site hernia as a

complication.

The mesh extrusion rate in the current study is comparable to the rates reported by a

recent meta‐analysis of RASC (1.7% vs. 0 – 19%)4. The single patient in the present series

who required operative repair of her exposed mesh had undergone concomitant total

hysterectomy. Previous studies have shown that concomitant total hysterectomy is

associated with a high incidence of mesh extrusion ranging from 16% to 23% after

sacrocolpopexy12, 13. Because of this analysis we now counsel the patients requiring

hysterectomy to undergo supracervical hysterectomy if there is no increases risk for

cervical cancer, and since that time, no additional mesh exposure events following

supracervical hysterectomy were noted in this series. In a recent study of 277 women

undergoing abdominal sacral colpopexy (not RASC) with either a concomitant

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7 supracervical hysterectomy or no hysterectomy because it had been done previously, the

authors found no difference in mesh extrusion in the supracervical group (2/195 =0.5%,

compared to 2/82 =2.4%) in the total hysterectomy group14.

Vaginal suture extrusion in our study is higher than another laparoscopic series (9.2% vs.

6%) 15. Most patients with suture extrusions presented with no symptoms, only noted by

the examining urologist. However, some may present with vaginal discharge or

dyspareunia. Vaginal suture extrusion is likely a technical error from placement of NON‐

absorbable sutures through full thickness of vagina. In an effort to minimize suture

extrusions, we switched to delayed absorbable polydioxanone sutures for mesh fixation.

A main concern with using absorbable sutures is the durability of mesh fixation. Porcine

models demonstrate that majority of the final strength of tissue in‐growth into

polypropylene mesh is achieved by 12 weeks postoperatively, and that 2 weeks yields

significantly lower bond of mesh to fascia16. Polydioxanone suture loses only 50% of its

tensile strength by 6 weeks, whereas Maxon® (polyglyconate) loses 50% of its strength by

3 weeks and Vicryl® by 2 weeks17. The rate of recurrent prolapse was not influenced by

the type of mesh fixation suture used in our study. A recent study by Borahay et al. also

found that delayed absorbable sutures is effective in RASC patients with no apical prolapse

at a median follow up of 17 months 18. A randomized controlled trial with longer follow‐

up is needed to address better address this issue.

There are several limitations in this study including those common to retrospective

reviews. The data came from a single institution, single surgeon, and the sample size is

small relative to the number of suture extrusion events. A trial to truly determine the

durability of delayed absorbable sutures would need to be randomized and blinded, but

the present work suggests results are equivalent.

Conclusions:

Securing mesh with DELAYED‐ABSORBABLE MONOFILAMENT does not appear to increase

risk of failure in patients undergoing RASC and eliminates the need for suture excision post

operatively. The technique for RASC described above yields durable outcomes equal to

that in the contemporary literature. This work justifies more study into the use of delayed

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8 absorbable sutures to secure polypropylene mesh during RASC, and more study is needed

before patients can be counseled that delayed absorbable suture can match permanent

suture for durability.

Page 9 of 18

9 REFERENCE

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sacrocolpopexy: a review. Eur Urol. 2009 May;55(5):1089‐103. PubMed PMID: 19201521.

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4. Serati M, Bogani G, Sorice P, et al. Robot‐assisted Sacrocolpopexy for Pelvic Organ

Prolapse: A Systematic Review and Meta‐analysis of Comparative Studies. Eur Urol. 2014

Mar 6. PubMed PMID: 24631406. Epub 2014/03/19. Eng.

5. Muffly TM, Diwadkar GB, Paraiso MF. Lumbosacral osteomyelitis after robot‐

assisted total laparoscopic hysterectomy and sacral colpopexy. Int Urogynecol J. 2010

Dec;21(12):1569‐71. PubMed PMID: 20532751. Epub 2010/06/10. eng.

6. Nosseir SB, Kim YH, Lind LR, Winkler HA. Sacral osteomyelitis after robotically

assisted laparoscopic sacral colpopexy. Obstet Gynecol. 2010 Aug;116 Suppl 2:513‐5.

PubMed PMID: 20664437. Epub 2010/07/29. eng.

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surgical complications: five‐year experience. Annals of surgery. 2009 Aug;250(2):187‐96.


8. Ploumidis A, Spinoit AF, De Naeyer G, et al. Robot‐assisted sacrocolpopexy for pelvic

organ prolapse: surgical technique and outcomes at a single high‐volume institution. Eur

Urol. 2014 Jan;65(1):138‐45. PubMed PMID: 23806518. Epub 2013/06/29. eng.

9. Nosti PA, Umoh Andy U, Kane S, et al. Outcomes of abdominal and minimally

invasive sacrocolpopexy: a retrospective cohort study. Female pelvic medicine &

reconstructive surgery. 2014 Jan‐Feb;20(1):33‐7. PubMed PMID: 24368486. Epub

2013/12/26. eng.

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10 10. Brubaker L, Nygaard I, Richter HE, et al. Two‐year outcomes after sacrocolpopexy

with and without burch to prevent stress urinary incontinence. Obstet Gynecol. 2008

Jul;112(1):49‐55. PubMed PMID: 18591307. Pubmed Central PMCID: 2614233. Epub

2008/07/02. eng.

11. Culligan PJ, Gurshumov E, Lewis C, et al. Subjective and objective results 1 year after

robotic sacrocolpopexy using a lightweight Y‐mesh. Int Urogynecol J. 2014 Jun;25(6):731‐5.


12. Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1‐year outcomes after

robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012 May;206(5):435 e1‐5.


13. Stepanian AA, Miklos JR, Moore RD, Mattox TF. Risk of mesh extrusion and other

mesh‐related complications after laparoscopic sacral colpopexy with or without concurrent

laparoscopic‐assisted vaginal hysterectomy: experience of 402 patients. J Minim Invasive

Gynecol. 2008 Mar‐Apr;15(2):188‐96. PubMed PMID: 18312989. Epub 2008/03/04. eng.

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15. Cundiff GW, Varner E, Visco AG, et al. Risk factors for mesh/suture erosion following

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18976976. Epub 2008/11/04. eng.

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Page 11 of 18

11 Abbreviations:

Robotic Assisted Sacral Colpopexy (RASC)

Polydiaxone delayed absorbable suture (PDS® )

pelvic organ prolapse (POP)

Pelvic Organ Prolapse Quantification (POP‐Q)

deep venous thrombus (DVT)

Page 12 of 18

12 Table 1

Table 1 Preop Demographics

Prolene® PDS®

Age (years) 62.1 ± 13.4 63.9 ± 10.0 p= NS

UDI‐6 12.1 ± 3.3 10.2 ± 5.1 p= NS

QoL 7.4 ± 3.0 6.8 ± 3.8 P= 0.01

BMI 28.8 ± 6.8 27.7 ± 5.2 p= NS

Diabetic 1 1 p= NS

Prior prolapse surgery 11 8 P= NS

Active Tobacco use 3 10 p= NS

steroid use 2 0 p= NS

POP‐Q‐ Preop

Aa + 0.6 + 0.8 p= NS

Ba + 2.1 + 2.4 p= 0.01

C ‐3.1 ‐3.7 p= NS

TVL 8.4 8.0 p= NS

Ap ‐0.4 ‐1.1 p= 0.01

Bp + 0.8 ‐0.2 p= NS

Page 13 of 18

13 Table 2 Outcomes for Sacral Colpopexy by suture type

Prolene® PDS®

UDI‐6 5.3 ± 4.0 5.1 ± 4.0 p= NS

QoL 2.8 ± 2.0 2.8 ± 2.2 p= NS

Follow up

(months) 23.0 ± 18.8 10.4 ± 11.2 p< 0.01

POP‐Q Postop

Aa ‐1.7 ‐2.1 p= NS

Ba ‐1.4 ‐1.9 p= NS

C ‐8.1 ‐8.5 p= NS

TVL 8.5 8.7 p= NS

Ap ‐2.1 ‐2.3 p= NS

Bp ‐1.7 ‐2.0 p= NS

Page 14 of 18

14 Table 3. Failure of repair by compartment and type of suture used to secure mesh. Suture

extrusion by suture type. Significance is by Chi‐Squared analysis.

REPAIR FAILURE Prolene® PDS®

at APEX 0 / 49 0 / 70 p= NS

at ANTERIOR compartment 6 / 49 1 / 70 p= 0.012

at POSTERIOR

compartment 3 / 49 1 / 70 p= NS

requiring excision

Prolene® suture erosion 9 / 49 7 / 9

PDS® suture erosion 2 / 70 0 / 2

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15 Figure Legends

Figure 1. Arm tucked and wrapped with foam, legs in stirrups.

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16

Figure 2. Port site locations on abdomen using 4‐Robotic arm setup.

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17

Figure 3. Bed mounted vaginal retractor prior to anchoring to bed.

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18

Figure 4. Bed mounted vaginal retractor after being anchored to bed.

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DOI: 10.1089/end.2018.0029 1 Securing Mesh with Delayed